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NDC 63824-0220-22 Delsym Cough Plus Chest Congestion DM and Delsym Cough Plus Cold Night Time Details
Delsym Cough Plus Chest Congestion DM and Delsym Cough Plus Cold Night Time
Delsym Cough Plus Chest Congestion DM and Delsym Cough Plus Cold Night Time is a KIT in the HUMAN OTC DRUG category. It is labeled and distributed by RB Health (US) LLC. The primary component is .
MedlinePlus Drug Summary
Acetaminophen is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, and reactions to vaccinations (shots), and to reduce fever. Acetaminophen may also be used to relieve the pain of osteoarthritis (arthritis caused by the breakdown of the lining of the joints). Acetaminophen is in a class of medications called analgesics (pain relievers) and antipyretics (fever reducers). It works by changing the way the body senses pain and by cooling the body.
Related Packages: 63824-0220-22Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Acetaminophen
Dextromethorphan is used to temporarily relieve cough caused by the common cold, the flu, or other conditions. Dextromethorphan will relieve a cough but will not treat the cause of the cough or speed recovery. Dextromethorphan is in a class of medications called antitussives. It works by decreasing activity in the part of the brain that causes coughing.
Related Packages: 63824-0220-22Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Dextromethorphan
Diphenhydramine is used to relieve red, irritated, itchy, watery eyes; sneezing; and runny nose caused by hay fever, allergies, or the common cold. Diphenhydramine is also used to relieve cough caused by minor throat or airway irritation. Diphenhydramine is also used to prevent and treat motion sickness, and to treat insomnia (difficulty falling asleep or staying asleep). Diphenhydramine is also used to control abnormal movements in people who have early stage parkinsonian syndrome (a disorder of the nervous system that causes difficulties with movement, muscle control, and balance) or who are experiencing movement problems as a side effect of a medication. Diphenhydramine will relieve the symptoms of these conditions but will not treat the cause of the symptoms or speed recovery. Diphenhydramine should not be used to cause sleepiness in children. Diphenhydramine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.
Related Packages: 63824-0220-22Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Diphenhydramine
Guaifenesin is used to relieve chest congestion. Guaifenesin may help control symptoms but does not treat the cause of symptoms or speed recovery. Guaifenesin is in a class of medications called expectorants. It works by thinning the mucus in the air passages to make it easier to cough up the mucus and clear the airways.
Related Packages: 63824-0220-22Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Guaifenesin
Phenylephrine is used to relieve nasal discomfort caused by colds, allergies, and hay fever. It is also used to relieve sinus congestion and pressure. Phenylephrine will relieve symptoms but will not treat the cause of the symptoms or speed recovery. Phenylephrine is in a class of medications called nasal decongestants. It works by reducing swelling of the blood vessels in the nasal passages.
Related Packages: 63824-0220-22Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Phenylephrine
Product Information
NDC | 63824-0220 |
---|---|
Product ID | 63824-220_bcfa0f19-e87d-4e96-8607-912d0c41bb98 |
Associated GPIs | 43998805406350 |
GCN Sequence Number | 080932 |
GCN Sequence Number Description | diphenhydram/PE/DM/acetamin/GG LIQUID SEQ 5-325MG/10 ORAL |
HIC3 | B4O |
HIC3 Description | NON-OPIOID ANTITUS-1ST ANTIHIST-DECON-ANALG-EXPECT |
GCN | 47921 |
HICL Sequence Number | 036616 |
HICL Sequence Number Description | DIPHENHYDRAMINE/PHENYLEPHRIN/DEXTROMETHORPH/ACETAMINOPHEN/GG |
Brand/Generic | Brand |
Proprietary Name | Delsym Cough Plus Chest Congestion DM and Delsym Cough Plus Cold Night Time |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | Acetaminophen, Dextromethorphan Hydrobromide, Diphenhydramine Hydrochloride, Guaifenesin, and Phenylephrine Hydrochloride |
Product Type | HUMAN OTC DRUG |
Dosage Form | KIT |
Route | n/a |
Active Ingredient Strength | n/a |
Active Ingredient Units | n/a |
Substance Name | n/a |
Labeler Name | RB Health (US) LLC |
Pharmaceutical Class | n/a |
DEA Schedule | n/a |
Marketing Category | OTC MONOGRAPH FINAL |
Application Number | part341 |
Listing Certified Through | 2023-12-31 |
Package
Package Images

NDC 63824-0220-22 (63824022022)
NDC Package Code | 63824-220-22 |
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Billing NDC | 63824022022 |
Package | 1 KIT in 1 CARTON (63824-220-22) * 180 mL in 1 BOTTLE (63824-213-66) * 180 mL in 1 BOTTLE (63824-211-66) |
Marketing Start Date | 2017-07-01 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 211b5ef8-0de8-441b-b1de-eba943d7c8b1 Details
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Uses
Delsym Cough+ Chest Congestion DM
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
- temporarily relieves:
- cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
- the intensity of coughing
- the impulse to cough
Warnings
Liver warning (Night Time only)
This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 6 doses in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks daily while using this product
Allergy alert (Night Time only)
Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
- blisters
- rash
If a skin reaction occurs, stop use and seek medical help right away.
Sore throat warning (Night Time only)
If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
Do not use
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. (Night Time only)
- with any other product containing diphenhydramine, even one used on the skin (Night Time only)
- if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Ask a doctor before use if you have
- liver disease (Night Time only)
- heart disease (Night Time only)
- high blood pressure (Night Time only)
- glaucoma (Night Time only)
- thyroid disease (Night Time only)
- diabetes (Night Time only)
- trouble urinating due to an enlarged prostate gland (Night Time only)
- a breathing problem such as emphysema or chronic bronchitis (Night Time only)
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- cough that occurs with too much phlegm (mucus)
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin (Night Time only)
- taking sedatives or tranquilizers (Night Time only)
When using this product
- do not use more than directed
- excitability may occur, especially in children (Night Time only)
- marked drowsiness may occur (Night Time only)
- alcohol, sedatives, and tranquilizers may increase drowsiness (Night Time only)
- avoid alcoholic drinks (Night Time only)
- be careful when driving a motor vehicle or operating machinery (Night Time only)
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occur (Night Time only)
- pain, nasal congestion, or cough gets worse or lasts more than 7 days (Night Time only)
- fever gets worse or lasts more than 3 days (Night Time only)
- redness or swelling is present (Night Time only)
- new symptoms occur (Night Time only)
- cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition.
Directions
- do not take more than directed (see Overdose warning)
- do not take more than 6 doses in any 24-hour period
- measure only with dosing cup provided
- do not use dosing cup with other products
- dose as follows or as directed by a doctor
- adults and children 12 years of age and older: 20 mL in dosing cup provided every 4 hours
- children under 12 years of age: do not use
Other information
Inactive ingredients (Delsym Cough+ Chest Congestion DM)
Inactive ingredients (Delsym Cough+ Cold Night Time)
anhydrous citric acid, edetate disodium, FD&C blue no. 1, FD&C red no. 40, flavors, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate1, xanthan gum
PRINCIPAL DISPLAY PANEL - Kit Carton
DAY
NIGHT
NDC 63824-220-22
COMBO
PACK
Delsym®
COUGH+®
CHEST
CONGESTION
DM
Dextromethorphan HBr (Cough Suppressant)
Guaifenesin (Expectorant)
- ✓
- Cough
- ✓
- Chest Congestion
- ✓
- Thins & Loosens Mucus
Cherry
Flavored Liquid
COUGH+®COLD
NIGHT TIME
Acetaminophen (Pain Reliever/Fever Reducer)
Diphenhydramine HCl (Antihistamine/Cough Suppressant)
Phenylephrine HCl (Nasal Decongestant)
- ✓
- Cough
- ✓
- Sore Throat
- ✓
- Fever
- ✓
- Nasal Congestion
- ✓
- Body Aches
Mixed Berry
Flavored Liquid
For Ages 12+
TWO–6 fl oz (180 mL) bottles
TOTAL–12 fl oz (360 mL)
For Ages 12+

INGREDIENTS AND APPEARANCE
DELSYM COUGH PLUS CHEST CONGESTION DM AND DELSYM COUGH PLUS COLD NIGHT TIME
acetaminophen, dextromethorphan hydrobromide, diphenhydramine hydrochloride, guaifenesin, and phenylephrine hydrochloride kit |
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Labeler - RB Health (US) LLC (081049410) |